The ingredient is at the center of a developing controversy, which was rekindled last week with the release of a study from a team headed by prominent dietary supplement industry critic Dr Pieter Cohen of Harvard Medical School. That study, published in the journal Drug Testing and Analysis and building on earlier work done by FDA’s own scientists in 2013, found that BMPEA was present in 11 of 21 products in the weight loss and sports categories that listed Acacia rigidula, a shrub native to Texas and Mexico,as the primary herbal ingredient on the label.
BMPEA, or beta-methylphenethylamine, is a positional isomer of amphetamine, and the senators’ letter noted that the earlier FDA study stated that if the chemical can be found in A. rigidula extracts at all it is present in such tiny quantities that the dosages found in the products must almost certainly have come from a synthesized form added after the fact. Cohen’s team came to the same conclusion, finding a top dosage of 94 mg, whereas the earlier FDA study found BMPEA present in 9 of 21 products studied in dosages ranging up to 146 mg. Products listing A. rigidula but not BMPEA on the label are misbranded under DSHEA, the letter points out.
BMPEA has never been studied in humans, at least so far as anyone can tell, so safety information is lacking. The ingredient is a central nervous system stimulant, and can be expected to have a range of side effects including increased heart rate, blood pressure and the risk of cardiovascular complications including increase risk of stroke.
“While the direct effects of BMPEA in the human body are not known, FDA should not wait for tragedy to strike to take action to warn consumers and to remove this mislabeled product,” they wrote.
NDI status
The letter also delves into the regulatory status of A. rigidula itself. The botanical does not appear to have been used much, if at all, prior to the beginning of this decade, so it seems an unlikely candidate for Old Dietary Ingredient status. And FDA, when queried recently on the matter, responded that no NDI notification is on file for either Acacia rigidula or the alternative (and according to at least one botanist, more correct) name of Vachellia rigidula (Benth.) Seigler & Ebinger. FDA said at the time that it has not yet determined the NDI/ODI status of the ingredient.
Durbin (D-IL) and Blumenthal (D-CN) are seeking clarification on this and other points, listing specific requests to be contained in a response including why FDA might or might not believe that an NDI notification is needed for either Acacia rigidula or BMPEA or if the agency has in fact received such notifications. The senators also want to know when FDA first knew that products labeled as A. rigidula might contain BMPEA.
Other specific requests what kind of communication FDA has with the manufacturers of the products it studied in 2013 and what kind of followup it did with those companies whose products were found to contain BMPEA. The letter also seeks clarification on how many adverse event reports the agency may have received on BMPEA and whether it has put out any warnings to consumers on the ingredient.
Finally, Durbin and Blumenthal are seeking a definitive declaration of how many staff the agency has devoted to the regulation of dietary supplements. The senators wrote they “hope this gives your agency an opportunity to reevaluate internal procedures to ensure there is robust oversight of dietary supplements.”